GlobalCOA – Indonesia 🇮🇩

Certificate of Analysis (COA) Preparation, Review & Testing Services

Indonesia-Compliant COAs. Regulatory-Ready. Export-Focused.

GlobalCOA, a professional service brand of Zoesoe Exports Pvt Ltd, provides end-to-end Certificate of Analysis (COA) preparation, review, and testing services in accordance with Indonesian regulatory requirements for products manufactured, marketed, or exported from Indonesia.

We support Indonesian manufacturers, exporters, traders, and brand owners with accurate, compliant, and authority-acceptable COAs, ensuring full compliance with Indonesian National Standards (SNI) and seamless acceptance in domestic and international markets.

🏛️ Regulatory Framework – Indonesia

GlobalCOA services are aligned with the requirements of key Indonesian regulatory and standards authorities:

• National Agency of Drug and Food Control (Badan POM / BPOM): The central authority regulating the safety, efficacy, and quality of Drugs (Pharmaceuticals), Traditional Medicines, Cosmetics, Food, and Health Supplements. BPOM registration and compliance are mandatory for market authorization.

  • Indonesian Pharmacopoeia (Farmakope Indonesia - FI): The official standard for pharmaceutical products.

• National Standardization Agency of Indonesia (Badan Standardisasi Nasional - BSN): The national body responsible for developing and publishing Indonesian National Standards (Standar Nasional Indonesia - SNI) and managing the national standardization system.

• National Accreditation Committee (Komite Akreditasi Nasional - KAN): The body responsible for accrediting testing, calibration, and certification bodies (ISO/IEC 17025, etc.).

• Ministry of Health (Kemenkes): Sets policies related to health services and certain regulated medical devices and materials.

• MUI / Halal Certification: Compliance with Halal requirements (often mandatory for food/cosmetics) may impose additional testing requirements.

🔬 Our GlobalCOA Services – Indonesia

We offer complete lifecycle support for Certificate of Analysis documentation as per Indonesian regulatory expectations:

✅ COA Preparation (Indonesia-Compliant)

• COA drafting aligned with BPOM Regulations (e.g., for Registration, Import Permit), the Indonesian Pharmacopoeia (FI) for drugs, and applicable SNI Standards for food/other products.

• Alignment with ASEAN Harmonization guidelines (e.g., ACTD for Pharmaceuticals) and international pharmacopoeias (USP / BP / EP) where required for export.

• Batch-wise, stability-based, and customer-specific COAs.

• COAs suitable for Product Distribution License (Izin Edar) applications to BPOM.

✅ COA Review & Regulatory Compliance Assessment

• Review of existing COAs for BPOM / FI / SNI compliance.

• Identification and correction of non-compliance issues:

  • Missing mandatory parameters as required by BPOM for specific product categories (e.g., heavy metals, specific contaminants).

  • Incorrect acceptance criteria or non-FI test methods.

• Harmonization with product specifications, Good Manufacturing Practice (CPOB/CPOTB/CPPB), and registration dossiers.

✅ Testing & Analytical Coordination (Indonesia)

• Testing coordination through KAN-accredited (ISO/IEC 17025) or BPOM-recognized laboratories.

• Method selection as per:

  • Indonesian Pharmacopoeia (FI) for pharmaceuticals.

  • SNI Standards or Codex Alimentarius for food and other products.

  • Validated in-house methods with justification.

• Support for re-testing, OOS/OOT investigations, and quality trend analysis.

📦 Product Categories Covered – Indonesia

GlobalCOA provides COA services for regulated sectors:

• 🔹 Pharmaceuticals & Health Products

  • APIs, Finished Drugs, and Excipients (aligned with FI).

  • Traditional Medicines (Obat Tradisional - OT) and Health Supplements.

• 🔹 Food & Beverages

  • Processed Food, Food Ingredients, and Nutritional Products (regulated by BPOM and BSN/SNI).

• 🔹 Cosmetics & Personal Care

  • Products regulated under BPOM Cosmetics Regulations.

• 🔹 Industrial Products

  • Materials requiring mandatory SNI certification or quality documentation for trade.

🏭 Industries We Serve – Indonesia

GlobalCOA supports regulated Indonesian industries including:

• Pharmaceuticals & APIs

• Traditional Medicine & Herbal Extracts

• Food & Beverage Manufacturing

• Cosmetics & Personal Care

• Industrial Chemical Manufacturing and Trading

🌟 Why Choose GlobalCOA for Indonesia?

• **✔ Deep understanding of BPOM Regulations and the Indonesian Pharmacopoeia (FI).

• ✔ COAs aligned with SNI Standards and ASEAN/ACTD guidelines.

• ✔ Strong coordination with KAN-accredited laboratories.

• ✔ Documentation suitable for Izin Edar (Distribution License) applications.

📝 Regulatory & Export Support – Indonesia

GlobalCOA COAs support critical processes in the Indonesian context:

• Product Distribution License (Izin Edar) applications to BPOM.

• Import/Export Documentation and customs clearance.

• Compliance with Halal certification requirements (where applicable).

• Supporting documentation for GMP (CPOB) and quality audits.

Our Indonesia-focused COAs ensure efficient BPOM submissions and smooth market access.

📞 Get Started with GlobalCOA – Indonesia

Whether you require new COA preparation, review of existing COAs, or testing support for Indonesian manufacturing or export batches, GlobalCOA by Zoesoe Exports Pvt Ltd is your trusted compliance partner.